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NDC 65162-0644-09 Esomeprazole Magnesium 20 mg/1 Details
Esomeprazole Magnesium 20 mg/1
Esomeprazole Magnesium is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is ESOMEPRAZOLE MAGNESIUM.
MedlinePlus Drug Summary
Prescription esomeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription esomeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription esomeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription esomeprazole is also used to decrease the chance that people who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the stomach or intestine) in adults. It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori) in adults. Prescription esomeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Nonprescription (over-the-counter) esomeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Related Packages: 65162-0644-09Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Esomeprazole
Product Information
| NDC | 65162-0644 |
|---|---|
| Product ID | 65162-644_93959bc8-20a5-4cc2-b76a-f3e98056d1ae |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Esomeprazole Magnesium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Esomeprazole Magnesium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/1 |
| Substance Name | ESOMEPRAZOLE MAGNESIUM |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209647 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 65162-0644-09 (65162064409)
| NDC Package Code | 65162-644-09 |
|---|---|
| Billing NDC | 65162064409 |
| Package | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-644-09) |
| Marketing Start Date | 2019-04-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |